Three Instructional Interventions for Prehospital Cervical Spinal Immobilization by Laypeople

University of Michigan

Status: Completed

Conditions: Cervical Vertebra Injury; Cervical Vertebra Fracture

Treatments: Behavioral: Instructional flashcard (version 1); Behavioral: Instructional flashcard (version 2); Behavioral: In-person training; Behavioral: Audio kit

Study type: Interventional

Funder types: Other

Identifiers

NCT05359575

HUM00210308

Details and patient eligibility

About

It is not known if bystanders equipped with point-of-care (POC) instruction are as effective as bystanders with in-person training for c-spine immobilization. Therefore, POC instructional interventions were developed during this study in response to the scalability challenges associated with in-person training to measure the comparative effectiveness and skill retention of POC instructions vs in-person training using a randomized clinical trial design.

Full description

Road traffic injuries (RTIs) are the largest contributor to the global injury burden, which disproportionately affects low- and middle-income countries (LMICs). Traumatic spinal cord injury (TSCI) is the highest contributor to years lived disabled (YLDs) resulting from RTIs, accounting for 74.8% of YLDs from RTI. With a lack of robust emergency medical services (EMS), there has been increasing reliance on layperson bystanders to respond to RTIs in LMICs. Early spinal immobilization has the potential to limit neurological deficits secondary to TSCI and morbidity. Bystanders may be trained in-person or point-of-care (POC) instruction may be provided, as exists with automated external defibrillators and tourniquets. However, it is unknown if bystanders equipped with POC instruction are as effective as bystanders with in-person training for c-spine immobilization. Therefore, POC instructional interventions were developed in response to the scalability challenges associated with in-person training to measure the comparative effectiveness and skill retention of POC instructions vs in-person training using a randomized clinical trial design. The POC instructional flashcard was first piloted with an initial cohort of participants who were not assigned to any longitudinal follow-up date to pilot POC instructional interventions for c-spine immobilization and receive feedback for instructional flashcard revision prior to launching the "trial." Data from these participants is not considered part of the "trial" for analytic purposes. This entire testing process is with participants who are healthy volunteers and researchers simulating spinal injury victims to test which method of instruction is most effective and durable for understanding.

Enrollment: 265 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Understand spoken and written English.

Exclusion criteria

• None

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Single Blind

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265 participants in 10 patient groups

Audio recording with instructional flashcard with cervical-collar ("audio kit") - 1 month follow-up

Experimental group

Description:

MP3 audio files for each of 6 steps (totaling 1 minute, 19 seconds) and instructional flashcard with seven pictures corresponding to each of the 6 steps of c-collar application, used for c-collar application attempt. Participants repeat the c-collar application with the audio kit at 1 month follow-up.

Treatment:

Behavioral: Audio kit

Behavioral: Instructional flashcard (version 2)

Instructional flashcard with cervical-collar - 1 month follow-up

Experimental group

Description:

Instructional flashcard with seven pictures corresponding to 6 steps of c-collar application, used for c-collar application attempt. Participants repeat the c-collar application with the instructional flashcard at 1 month follow-up.

Treatment:

Behavioral: Instructional flashcard (version 2)

In-person training with cervical-collar - 1 month follow-up

Experimental group

Description:

10 minutes of a Lay First Responder (LFR) spinal immobilization course (extracted from the current LFR Level 1 trauma course) are used for instruction for c-collar application attempt. Participants repeat the c-collar application without any POC instruction or re-training at 1 month follow-up.

Treatment:

Behavioral: In-person training

Control group with no in-person training and no access to POC instruction - 1 month follow-up

No Intervention group

Description:

There is no in-person training or point-of-care (POC) instructional interventions for this group for c-collar application attempt. Participants repeat the c-collar application without any in-person training or POC instructional interventions at 1 month follow-up.

Audio recording with instructional flashcard with cervical-collar ("audio kit") - 2 Months follow-up

Experimental group

Description:

MP3 audio files for each of 6 steps (totaling 1 minute, 19 seconds) and instructional flashcard with seven pictures corresponding to each of the 6 steps of c-collar application, used for c-collar application attempt. Participants repeat the c-collar application with the audio kit at 2 months follow-up.

Treatment:

Behavioral: Audio kit

Behavioral: Instructional flashcard (version 2)

Instructional flashcard with cervical-collar - 2 months follow-up

Experimental group

Description:

Instructional flashcard with seven pictures corresponding to 6 steps of c-collar application, used for c-collar application attempt. Participants repeat the c-collar application with the instructional flashcard at 2 months follow-up.

Treatment:

Behavioral: Instructional flashcard (version 2)

In-person training with cervical-collar - 2 months follow-up

Experimental group

Description:

10 minutes of a Lay First Responder (LFR) spinal immobilization course (extracted from the current LFR Level 1 trauma course) are used for instruction for c-collar application attempt. Participants repeat the c-collar application without any POC instruction or re-training at 2 months follow-up.

Treatment:

Behavioral: In-person training

Control group with no in-person training and no access to POC instruction - 2 months follow-up

No Intervention group

Description:

There is no in-person training or POC instructional interventions for this group for c-collar application attempt. Participants repeat the c-collar application without any in-person training or POC instructional interventions at 2 months follow-up.

Audio recording with instructional flashcard (version 1) with cervical-collar - no follow-up

Experimental group

Description:

Prior to randomization to 1 or 2 month follow up, these participants served as an initial cohort of participants who were not assigned to any longitudinal follow-up date so that the POC instructional flashcard could first be piloted to receive feedback for instructional flashcard revision prior to launching the "trial" after participants expressed concern about ambiguity in the instructional flashcard. Data from these participants is not considered part of the "trial" for any analytic purposes. Revisions to the instructional flashcard were made.

Treatment:

Behavioral: Audio kit

Behavioral: Instructional flashcard (version 1)

Instructional flashcard (version 1) with cervical-collar - no follow-up

Experimental group

Description:

Prior to randomization to 1 or 2 month follow up, these participants served as an initial cohort of participants who were not assigned to any longitudinal follow-up date so that the POC instructional flashcard could first be piloted to receive feedback for instructional flashcard revision prior to launching the "trial" after participants expressed concern about ambiguity in the instructional flashcard. Data from these participants is not considered part of the "trial" for any analytic purposes. Revisions to the instructional flashcard were made.

Treatment:

Behavioral: Instructional flashcard (version 1)